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Back To Vidyya No Over The Counter Status For Statins

Despite Pressure From HMOs, FDA Refuses OTC Status For Popular Drugs

Food and Drug Administration advisers on Friday voted against allowing the cholesterol-lowering medication Pravachol (pravastatin), made by Bristol-Myers Squibb, to be sold directly to consumers in pharmacies.

On Thursday, the same advisers voted against switching Merck & Co.'s cholesterol-lowering drug Mevacor (lovastatin) from prescription to over-the-counter (OTC) use.

Panelists said that Pravachol was very safe, as long as people who have heart disease or diabetes don't take the drug. They also said that the company almost swayed them that consumers could safely and effectively use Pravachol without stringent oversight from physicians.

"This product comes really close to what I'd like to see," said panelist Marie Gelato of the State University of New York at Stonybrook's Health Science Center.

She and other committee members recommended that Bristol-Myers study again how well consumers understand OTC Pravachol's label and that they target a narrower patient population. Bristol-Myers was recommending that Pravachol, 10 mg a day, be used in men over age 35 and women over age 45 who had total cholesterol of 200-240 mg/dl and LDL, or "bad" cholesterol greater than 130 mg/dl.

Although the agency is not bound by the panel's recommendation, the FDA usually follows its panels' advice.

Both Bristol-Myers and Merck argued that if their products were more widely available, more consumers would seek treatment for elevated cholesterol, a risk factor for cardiovascular disease.

Most people with total cholesterol of 200-240 mg/dl are told to change their diets and increase exercise to reduce total cholesterol and LDL. There is some debate whether these people are at higher risk for heart disease, heart attacks, and strokes. Bristol-Myers Squibb consultant Jerome Cohen of the St. Louis University Preventive Cardiology Program argued that they are and that they should be treated.

"We should strive for an optimal cholesterol level," said Cohen, noting that the National Cholesterol Education Program describes those optimal values as less than 200 mg/dl for total cholesterol and less than 130 mg/dl for LDL.

In considering a drug for OTC use, the FDA looks at safety and efficacy, and whether the target population will appropriately use the product, and whether they will understand how to take proper doses, how long to take the drug, and the long term benefits, said David Orloff, deputy director of the FDA's division of metabolic and endocrinologic drugs.

These questions are especially important for Pravachol, since, unlike other OTC drugs, it is for a condition that has no symptoms and is potentially life-threatening, he said.

Bristol-Myers conducted several studies that it said showed that consumers would understand who should and should not take Pravachol and that they should consult with a physician when taking the drug.

Karen Lechter of the FDA's Division of Drug Marketing, Advertising and Promotion, agreed that these points were well understood. But, she said, it wasn't clear if the study subjects understood the need for dietary and lifestyle changes in addition to Pravachol, and if they knew what's considered a healthy cholesterol level. There is also some potential for misuse, she said, noting that 17% said that Pravachol was appropriate for total cholesterol of 250-300 mg/dl.

Bristol-Myers also studied whether people would follow directions in both a contrived pharmacy situation and a "real-world" retail setting. The vast majority of OTC purchasers in both studies had been told they had high cholesterol, and thus appropriately self-diagnosed and bought Pravachol, said Bristol-Myers.

Most patients also consulted a physician within 2 months of starting the drug. The company also said that most had a reduction in cholesterol levels that brought them in line with NCEP goals.

The FDA, though, pointed out that only half the patients taking Pravachol in both studies took their medication as recommended on the label, which means that benefits might not be long-lasting. The agency also questioned whether people could self-diagnose with high cholesterol, pointing out that 21% of those queried in one Bristol-Myers study did not know a healthy total cholesterol level was under 200 mg/dl.

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Editor: Susan K. Boyer, RN
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